Dog-rose, Cranberry Leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica and Sumac in Diabetes Mellitus
NCT ID: NCT05700513
Last Updated: 2023-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2023-07-28
2025-02-28
Brief Summary
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Detailed Description
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A pilot study with 30 participants will be conducted to estimate the sample size considering 0.05 first type error and a power of 80%. Individuals aged between 18-70 with a diagnosis of type 2 diabetes mellitus based on WHO criteria for at least one year will be enrolled. Participants will be randomized in the placebo or intervention group to receive two capsules per day before lunch and dinner for six months containing 200 milligrams of equally combined extracts of Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, Dog-rose, and Sumac. Participants will be followed up with four office visits (t0= baseline, 1=15th day, 2t=3rd month, 3t=6th month) to assess outcomes. Also, the complications and adherence of patients to intervention will be checked every two weeks by telephonic discussion. The analysis will be performed based on the intent-to-treat method.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Capsules containing the combination products
Capsules containing dog-rose, Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, and Sumac
Capsules containing the combination products
Capsules containing dog-rose, Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, and Sumac
Placebo
Placebo capsules containing maltodextrin
Placebo capsules
Placebo capsules containing maltodextrin
Interventions
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Capsules containing the combination products
Capsules containing dog-rose, Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, and Sumac
Placebo capsules
Placebo capsules containing maltodextrin
Eligibility Criteria
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Inclusion Criteria
* Hemoglobin A1c (HbA1c) \> 7.0% or fasting blood glucose \> 7.0 mmol/L,
* Body mass index (BMI) more than 23 kg/m2 and less than 35.
Exclusion Criteria
* Pregnancy,
* Patients with a BMI over 35 who were on a weight loss diet or had taken weight loss supplements for less than 6 months
* A history of allergy to one of the components of the nestling fruit, carob leaf, carob fruit, alfalfa seed, fenugreek seed, lemon, Nettles and sumac and also
* Lactating women
* Regularly consuming cigarettes or alcohol
* Using psychiatric drugs or insulin
* Changing in the medication regimen during the trial period. For example, to start receiving insulin therapy, become pregnant, or no longer follow medication and dietary instructions.
18 Years
70 Years
ALL
No
Sponsors
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Tabriz University of Medical Sciences
OTHER
Responsible Party
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Dr. Saeid Safiri
Principal Investigator
Locations
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Imam Reza hospital and clinic of Salamat
Tabriz, AzarbayejaneShargi, Iran
Countries
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Central Contacts
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Other Identifiers
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70746
Identifier Type: -
Identifier Source: org_study_id
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